MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS PRIME - 423281

Model Number	423281
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: vitek® ms prime is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms prime system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.The vitek® ms prime system is intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.Issue description: a customer in the united states notified biomérieux of obtaining a misidentification of a corynebacterium species as brucella species in association with the vitek® ms prime (ref (b)(4), serial (b)(6)).The customer reported that they obtained an identification of brucella species with initial testing using the vitek ms prime.The identification to brucella species was unable to be reproduced and the organism was confirmed to be corynebacterium.Vitek ms prime: brucella species expected: corynebacterium species there is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health of the patient.An investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of obtaining a misidentification of a corynebacterium species as brucella species in association with the vitek® ms prime (ref (b)(4) , serial (b)(6).Complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the customer's issue as a trend for the vitek ms prime.Investigation: it was not possible to investigate regarding this specific misidentification because no data have been received.The customer declined to pursue an investigation and did not provide the data necessary to investigate the issue further.Root cause: the cause for the customer's issue could not be determined since the customer did not provide the strain for testing or any data for further analysis.Conclusion.The investigation could not find any evidence of a product performance issue.As the customer did not provide any strains or data for analysis, no further investigation could be completed.The customer's claimed issue of a misidentification of a corynebacterium as brucella has not been identified as a trend for the vitek ms prime.

• Brand Name: VITEK MS PRIME - 423281
• Common Device Name: VITEK MS PRIME - 423281
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 17363684
• Report Number: 9615754-2023-00036
• Device Sequence Number: 6068810
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown